A Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period

• Register: ClinicalTrials.gov
• Last refreshed on: 3 April 2023
• Main ID: NCT02587195
• Date of registration: 22/09/2015
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Nice
• Public title: A Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period TERICIS
• Scientific title: A National, Multi-center Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period
• Date of first enrolment: December 18, 2015
• Target sample size: 5
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02587195
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients enrolled in TOPIC study and extension of TOPIC study and currently treated in
French extension of TOPIC study who did not convert into MS.

- A baseline MRI scan (performed less than 2 months before baseline Visit ) confirming
that patient is still in CIS status.

Exclusion Criteria:

- Contraindication for MRI,

- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major
systemic disease or procedure/medication making implementation of the protocol or
interpretation of the study results difficult or that would put the patient at risk by
participating in the study

- Patients with a congenital or acquired severe immunodeficiency, a history of cancer
(except for basal or squamous cell skin lesions which have been surgically excised,
with no evidence of metastasis), lymphoproliferative disease, or any patient who has
received lymphoid irradiation

- Known history of active tuberculosis not adequately treated

- Persistent significant or severe infection

- History of drug or alcohol abuse

- Patients must not have used Adrenocorticotrophic hormone (ACTH) or systemic
corticosteroids for 2 weeks prior to inclusion

- Prior use within 4 weeks before inclusion or concomitant use of cholestyramine

- Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant
agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or
mycophenolate

- Prior or concomitant use of interferons, cytokine therapy, glatiramer acetate or
intravenous immunoglobulins

- Prior or concomitant use of natalizumab (Tysabri®)

- Pregnant or breast-feeding women

- Women of childbearing potential not protected by effective contraceptive method of
birth control and/or who are unwilling or unable to be tested for pregnancy.

- Women wishing to become pregnant during the course of the trial

- Patients with significantly impaired bone marrow function or significant anemia,
leukopenia, or thrombocytopenia

- Human immunodeficiency virus (HIV) positive patient

- Persisting elevations (confirmed by retest) of serum amylase or lipase greater than
2-fold the upper limit of normal

- Known history of chronic pancreatic disease or pancreatitis

- Liver function impairment or persisting elevations (confirmed by retest) of serum
glutamic pyruvic transaminase (SGPT/ALT), serum glutamic oxaloacetic transaminase
(SGOT/AST), or direct bilirubin greater than 1.5-fold the upper limit of normal

- Known history of active hepatitis

- Hypoproteinemia (e.g., in case of severe liver disease or nephrotic syndrome) with
serum albumin < 3.0 g/dL

- Moderate to severe impairment of renal function, as shown by serum creatinine > 133
µmol/L (or > 1.5 mg/dL)



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Teriflunomide

Primary Outcome(s)

Adverse event reporting [Time Frame: throughout study completion an average of 6 months]

Adverse Events That Are Related to Treatment [Time Frame: throughout study completion an average of 6 months]

Secondary Outcome(s)

Conversion based on Clinical evaluation [Time Frame: throughout study completion an average of 6 months]

volume of abnormal brain tissue on MRI [Time Frame: 3 years]

Quality of life using SF-36 [Time Frame: throughout study completion an average of 1 year]

Disability progression defined as a 1.0-point increase in EDSS score [Time Frame: confirmed after at least 12 weeks]

Proportion of disability-free subjects as assessed by the EDSS [Time Frame: throughout study completion an average of 1 year]

Fatigue Impact Scale [Time Frame: throughout study completion an average of 1 year]

Conversion based on annualized relapse rate (ARR) [Time Frame: throughout study completion an average of 6 months]

Conversion based on MRI [Time Frame: throughout study completion an average of 6 months]

Secondary ID(s)

15-PP-06

Source(s) of Monetary Support

Please refer to primary and secondary sponsors